RECRUITING

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Official Title

A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

Quick Facts

Study Start:2024-02-28
Study Completion:2030-09-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05827081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC).
  2. * Participant has HER2-negative breast cancer.
  3. * Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.
  4. * Participant has no contraindication to receive adjuvant ET in the study.
  5. * Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:
  6. * Anatomic Stage Group III, or
  7. * Anatomic Stage Group IIB, or
  8. * A subset of Anatomic Stage Group IIA
  9. * Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
  10. * Participant has adequate bone marrow and organ function.
  11. * ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:
  12. * QTcF interval at Screening \< 450 msec (QT interval using Fridericia's correction).
  13. * Mean resting heart rate 50-99 beats per minute (determined from the ECG).
  1. * Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
  2. * Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.
  3. * Participant has any other concurrent severe and/or uncontrolled medical condition.
  4. * Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
  5. * Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111
novartis.email@novartis.com

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
United States
Summit Cancer Care PC
Savannah, Georgia, 31405
United States
Hope And Healing Care
Hinsdale, Illinois, 60521
United States
Mercy Medical Center
Baltimore, Maryland, 21202
United States
Jackson Oncology Associates
Jackson, Mississippi, 39202
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-28
Study Completion Date2030-09-20

Study Record Updates

Study Start Date2024-02-28
Study Completion Date2030-09-20

Terms related to this study

Keywords Provided by Researchers

  • Hormone receptor positive (HR+)
  • Human epidermal growth factor receptor-2 negative (HER2-)
  • Early breast cancer (EBC)
  • premenopausal
  • postmenopausal
  • male breast cancer
  • ribociclib
  • LEE011
  • Endocrine therapy (ET)

Additional Relevant MeSH Terms

  • Early Breast Cancer